Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure

Danube Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma; Ocular Hypertension; Elevated IOP

Treatments: Drug: DNB-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683501

DNB-001-CT001

EudoraCT 2006-003907-38

Details and patient eligibility

About

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients with intraocular Hypertension

Full description

To evaluate the efficacy of four dosages of mg DNB-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with ocular hypertension.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline.

Exclusion criteria

• Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma
• Evidence of potential angle closure by gonioscopy
• Abnormal optic disc or visual field consistent with glaucoma
• Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

dosage X mg BID

Treatment:

Drug: DNB-001

2

Experimental group

Description:

dosage Y mg BID

Treatment:

Drug: DNB-001

3

Experimental group

Description:

dosage Z mg BID

Treatment:

Drug: DNB-001

4

Experimental group

Description:

dosage 2Z mg BID

Treatment:

Drug: DNB-001

5

Placebo Comparator group

Description:

Placebo BID

Treatment:

Drug: DNB-001